| Drug NDC: | 55714-2438 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | |
| Proprietary Name: | Feminine Comfort |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary Name: | Agaricus Musc., Arsenicum Alb., Aur. Met., Berber. Aqui., Caladium Seguinum, Candida Albicans, Cantharis, Conium, Graphites, Helonias Dioica, Hydrastis, Kali Carb., Kreosotum, Lycopodium, Merc. Viv., Murex Purpurea, Nat. Mur., Nitricum Ac., Pulsatilla, Rhus Toxicodendron, Sepia, Sulphur, Tarentula Hispana, Thuja Occ., Zinc. Met., Apis Mel., Hamamelis |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Newton Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | AMANITA MUSCARIA FRUITING BODY - 15 [hp_X]/mL ANEMONE PULSATILLA - 15 [hp_X]/mL APIS MELLIFERA - 6 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL BERBERIS AQUIFOLIUM ROOT BARK - 15 [hp_X]/mL CANDIDA ALBICANS - 15 [hp_X]/mL CHAMAELIRIUM LUTEUM ROOT - 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP - 15 [hp_X]/mL DIEFFENBACHIA SEGUINE - 15 [hp_X]/mL GOLD - 15 [hp_X]/mL Load more... GOLDENSEAL - 15 [hp_X]/mL GRAPHITE - 15 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 6 [hp_X]/mL HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL LYCOSA TARANTULA - 15 [hp_X]/mL LYTTA VESICATORIA - 15 [hp_X]/mL MERCURY - 15 [hp_X]/mL NITRIC ACID - 15 [hp_X]/mL POTASSIUM CARBONATE - 15 [hp_X]/mL SEPIA OFFICINALIS JUICE - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [hp_X]/mL SULFUR - 15 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/mL WOOD CREOSOTE - 15 [hp_X]/mL ZINC - 15 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Start Date: | 31 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Newton Laboratories, Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 N0000185372 M0008890 N0000185508 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | DIF093I037 I76KB35JEV 7S82P3R43Z S7V92P67HO VZJ9F3C3SB 4D7G21HDBC DQV54Y5H3U Q28R5GF371 01800C6E6B 79Y1949PYO Load more... ZW3Z11D0JV 4QQN74LH4O T7S323PKJS IQV54TN60Y C88X29Y479 86M454L2TT 3Q034RO3BT FXS1BY2PGL 411VRN1TV4 BQN1B9B9HA QDL83WN8C2 451W47IQ8X 70FD1KFU70 1NT28V9397 6IO182RP7A 3JYG22FD73 J41CSQ7QDS |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Standardized Insect Venom Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Bee Venoms [CS] Fungal Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Fungal Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] Standardized Insect Venom Allergenic Extract [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 55714-2438-1 | 30 mL in 1 BOTTLE, GLASS (55714-2438-1) | 31 Jan, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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